Details for New Drug Application (NDA): 064097
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NDA 064097 describes DOXORUBICIN HYDROCHLORIDE, which is a drug marketed by Actavis Inc, Almaject, Amneal, Fresenius Kabi Usa, Gland, Hikma, Hisun Pharm Hangzhou, Hlthcare, Mylan Labs Ltd, Pfizer, Pharmachemie Bv, Pharmobedient, Sagent Pharms, Sun Pharm Inds, Teva Pharms Usa, Alembic, Ayana Pharma Ltd, Baxter Hlthcare Corp, Dr Reddys, Lupin, Sun Pharm, and Zydus Lifesciences, and is included in twenty-six NDAs. It is available from nine suppliers. Additional details are available on the DOXORUBICIN HYDROCHLORIDE profile page.
The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
The generic ingredient in DOXORUBICIN HYDROCHLORIDE is doxorubicin hydrochloride. There are seventeen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the doxorubicin hydrochloride profile page.
Summary for 064097
| Tradename: | DOXORUBICIN HYDROCHLORIDE |
| Applicant: | Hikma |
| Ingredient: | doxorubicin hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 064097
| Mechanism of Action | Topoisomerase Inhibitors |
Medical Subject Heading (MeSH) Categories for 064097
Suppliers and Packaging for NDA: 064097
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 064097 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9087 | 0143-9087-01 | 1 VIAL, MULTI-DOSE in 1 BOX (0143-9087-01) / 100 mL in 1 VIAL, MULTI-DOSE |
| DOXORUBICIN HYDROCHLORIDE | doxorubicin hydrochloride | INJECTABLE;INJECTION | 064097 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9091 | 0143-9091-01 | 1 VIAL, MULTI-DOSE in 1 BOX (0143-9091-01) / 100 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/100ML | ||||
| Approval Date: | Sep 13, 1994 | TE: | AP | RLD: | No | ||||
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